(71 days)
Not Found
No
The device description and intended use focus on the physical properties and application of bone cement, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a bone cement used for fixation of prostheses to bone or for fixation of pathological fractures. While it assists in the outcome of therapeutic procedures, it is a material used for fixation and not a therapeutic device itself in the sense of delivering treatment or therapy.
No
The device is a bone cement used for fixation of prostheses and pathological fractures, not for diagnosing medical conditions. Its intended use is therapeutic/fixation, as indicated by "fixation of prostheses to living bone" and "fixation of pathological fractures."
No
The device description clearly describes a physical bone cement product consisting of polymeric powder and liquid monomer, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the bone cement is used for the fixation of prostheses to living bone and for the fixation of pathological fractures. This is a direct therapeutic and structural application within the body.
- Device Description: The description details a material (polymeric powder and monomer) that is mixed and applied directly to bone during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This bone cement is used in vivo (within the body) for a structural and fixation purpose.
N/A
Intended Use / Indications for Use
Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living osteoorthritis treasedie musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to transmal or other conditions, or revision of a previous arthroplastical posted bone coment is also indivors, or revision of a fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Product codes
87 LOD
Device Description
Simplex™ P SpeedSet Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack of 10-pack of 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex™ P SpeedSet Bone Cement is approximately 4.8 minutes, with a dough time of 2.53 minutes and a setting time of 8.2 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PMA N17004, K030902
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
JAN 2 6 2006
Image /page/0/Picture/1 description: The image contains the word "Stryker" in a bold, sans-serif font, followed by the letter "K" and the number "053198" in a handwritten style. Below "Stryker", the word "Howmedica" is written in a bold, sans-serif font. Underneath "Howmedica", the word "OSTEONICS" is written in a regular, sans-serif font.
510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement
325 Corporate Drive Mahwah, NJ USA 07430
| Proprietary Name: | Simplex TM P SpeedSet Bone Cement |
|---|---|
| Common Name: | PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone cement |
| 21 CFR §888.3027 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LOD - Polymethylmethacrylate (PMMA) bone cement. |
| Device Manufacturer: | Howmedica International S. de R.L. |
| Raheen Business Park, Limerick, Ireland | |
| For Information contact: | Tiffani Rogers |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5412 | |
| Fax: (201) 831-6038 | |
| E-Mail: Tiffani.Rogers@stryker.com | |
| Date Summary Prepared: | November 14, 2005 |
Device Description
Simplex™ P SpeedSet Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack of 10-pack of 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex™ P SpeedSet Bone Cement is approximately 4.8 minutes, with a dough time of 2.53 minutes and a setting time of 8.2 minutes.
1
Indications For Usc:
Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living osteoorthritis treasedie musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to transmal or other conditions, or revision of a previous arthroplastical posted bone coment is also indivors, or revision of a fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Substantial Equivalence:
The Simplex™ P SpeedSet bone cement has the same indications, same liquid monomer and similar powder component as Simplex™ P bone cement. Additionally, the Simplex™ P SpeedSet bone cement is similar in dough time, setting time, setting time and working time as Palacos R bone cement. Howmedica Osteonics Corp. believes the SimplexTM P SpeedSet bone cement to be substantially equivalent to Simple® I bone cement approved in PMA N17004 and Palacos R bone cement to Smpless P bone
cement approved in PMA N17004 and Palacos R bone cement cleared in K030902.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three stylized lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2006
Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K053198/S1
Trade/Device Name: Simplex PTM SpeedSet Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: LOD Dated: January 18, 2006 Received: January 19, 2006
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Tiffani Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
25
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K1253199
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications
Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid ecthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen discase, severe joint destruction secondary to trauma or other conditions, or revision of a previous arthroplasty. Simplex™ P SpeedSet bone cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Prescription Use X (Per 21 CFR 801.109)
OR Over-the-Counter Use
(Please Do Not Write Below This Line – Continue on Another Page if Needed)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KoS31 99